Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05062967
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2021-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Organization:
Study Overview
Official Title:
Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to evaluate the prevalence and the clinical impact of Orthohepevirus C infection in different human populations, and to determine its zoonotic origin comparing the sequences obtained in both human and animal populations. This is an ambispective study where Orthohepevirus C infection will be evaluated in four high risk human population: i) patients with acute hepatitis, ii) patients with positive IgM antibody against Hepatitis E virus infection with undetectable viral load, iii) HIV infected individuals, and iv) solid organ transplant recipients. Furthermore, we will analyze three animal populations: i) suburban rodents, ii) domestic rodents, iii) wild carnivores. Viral sequences identified in both human and animal populations will be compared to evaluate the zoonotic origin of the infections.
Detailed Description:
To carry out the project a database will be created in electronic format, where the study team will integrate epidemiological, clinical and laboratory tests data of patients. Data will be anonymous and coded by a data manager.
Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin
Secondary objectives are:
1. To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
2. To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
3. To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
4. To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
5. To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
6. To evaluate the prevalence of infection by Ortho-C in wild carnivores
7. To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals
Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin
Secondary objectives are:
1. To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
2. To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
3. To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
4. To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
5. To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
6. To evaluate the prevalence of infection by Ortho-C in wild carnivores
7. To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: